Staff Engineer, Drug Substance, MSAT

Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.    WHAT  we do is every bit as important as  HOW  we do it! Our work together is guided by four enduring core values:   *RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.   *AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.   *LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.   *MODEL EXCELLENCE:  The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making. Summary: Vaxcyte is looking for an energetic and talented individual to join the Manufacturing Science and Technology (MSAT) team in the role of Drug Substance (DS) Staff Engineer. The incumbent will support the conjugation manufacturing operations from commercial readiness through PPQ and ongoing commercial production, onsite at contract manufacturing organizations (CMO), with the primary responsibility to provide technical and operational support of manufacturing operations that ensure robust and efficient manufacturing processes. This position will primarily be located in Visp, Switzerland.  This position will require the candidate to manage the highly complex conjugation manufacturing processes for Vaxcyte’s vaccine portfolio. This is an exciting opportunity to join an outstanding team, with a mission to support late-stage clinical manufacture, launch, and commercial operations for the PCV franchise.  The successful candidate will have the following skills and qualities: A skilled process engineer with expertise in: Molecule activation and bioconjugation (e.g., activation chemistries, conjugation reaction kinetics, in-process controls, and common side reactions/impurities) Strong quantitative skills: trend and multivariate analysis of process and analytical data to support continued process verification (CPV), deviation investigations, and process characterization (e.g., DOE). An exceptional team player who works seamlessly with others, speaks up, and remains focused on achieving the best results to attain company goals. The ability to analyze data and communicate conclusions, decisions and recommendations concisely to key stakeholders. A strong sense of ownership and accountability; commitment to Vaxcyte’s mission of protecting humankind. Essential Functions: Work cross functionally with program management, process development, quality, facilities, regulatory, finance, logistics, clinical supply, and CMO / supplier management to ensure manufacture under GMP of different protein-polysaccharide conjugate Drug Substances required for Vaxcyte’s vaccine portfolio. Execute statistical thinking and data analysis using: DOE planning/analysis, process capability, control charts/CPV trending, and clear data visualization; proficiency with common tools. Oversight of CMO service provider(s) to ensure delivery of commercial readiness, process validation, and commercial stage manufacturing campaigns. Enable MSAT DS team participation in technology transfer, equipment/technology procurement and qualification, late-stage process characterization, process validation, and deviation and deficiency investigations and troubleshooting. Lead all aspects of and engage in the planning, design, execution, and documentation of DS manufacturing process Investigations and CAPAs. Drive continuous improvement and change management in DS manufacturing processes through technological innovation and application of first principles in process engineering. Support the process to select new CMOs and suppliers. Leverage literature, industry/regulatory guidance, and practical experience to perform work and influence CMC strategies. Recommend and implement new technology that advances knowledge and productivity within the department. Drive continuous improvement. Author and review technical reports, manufacturing documents, regulatory submissions, and publications. Present at department, project team, and senior management meetings. May present externally at scientific conferences. Support the CMOs during inspections of health authorities where necessary and ensure proper follow-up of any potential observation or recommendation. Requirements:  PhD in Bio/Chemical Engineering or Microbiology/Chemistry/Biochemistry with 9+ years of relevant Pharma/Biotech industry experience, or Master’s degree in Bio/Chemical Engineering or Microbiology/Chemistry/ Biochemistry with 12+ years of relevant Pharma/Biotech industry experience. Other combinations of education and/or experience may be considered. Demonstrated capability in statistical thinking and data analysis: DOE planning/analysis, process capability, control charts/CPV trending, and clear data visualization; proficiency with common tools. Experience with Vaccine manufacturing operations preferred. Strong experience in Drug Substance Manufacturing under GMP regulations required. Understanding of Quality systems. Experience in Drug Substance manufacturing equipment specification and qualification preferred. Strong scientific or technological (process engineering) background and hands-on experience with biochemical reaction, product recovery, and purification processes. Commercial manufacturing experience preferred. Deep knowledge of protein‑polysaccharide conjugation principles (activation/coupling chemistries, reaction kinetics, impurity formation, and linkage distribution), plus understanding of CQAs and analytical characterization relevant to conjugates. Sound knowledge of product recovery unit operations such as homogenization/microfluidization, centrifugation, and depth filtration product purification unit operations such as chromatography, UF/DF TFF, and precipitation process analytics/control systems. Strong ability in troubleshooting equipment/technology and process. Adept at FMEA. Excellent analytic skills. Experience in Investigations and development and implementation of CAPAs preferred. Experience with facility fit assessment, facility start-up, technology transfer, process validation, and scale-down studies implementing DOE desired. Strong interpersonal and leadership skills. Ability to communicate effectively both verbally and in written formats. Experience with Cross-Functional teams and managing direct reports. Proven technical leadership skills including strong project management skills. Fluency in spoken and written English is highly preferred. Reports to: Associate Director, MSAT Bioconjugates   Location: Visp, Switzerland   Work Arrangement: Onsite    Compensation: The compensation package will be competitive and includes an equity component.   Relocation:  This role is not eligible for relocation assistance.  Equal Opportunity We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. Recruitment Fraud Notice Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at  vaxcyte.com/careers .  

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